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Real-World Study of PADN for the Treatment of PAH

NCT07039604 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-06-26

No results posted yet for this study

Summary

Real-World Study of PADN for the Treatment of PAH

Conditions

  • Pulmonary Hypertension
  • Hypertension, Pulmonary Arterial

Interventions

DEVICE

Enhancor™ Radiofrequency Catheter, Pulnovo Medical (Wuxi) CO., Ltd., Wuxi, Jiangsu, China

PADN: Contrast pulmonary artery (PA) angiography will be performed to localize the pulmonary artery bifurcation level and calculate the PA diameter. Once the anatomy deemed acceptable, the radiofrequency ablation catheter will be introduced into ostium of the left PA and the distal bifurcation area of the main PA. The catheter will be manoeuvred within the PA to allow energy delivery in a circumferential manner to ensure that the electrodes are tightly in contact with the endovascular surface. About three ablations at 45-55 # for 120 seconds each will be performed in ostium of the left PA and the distal bifurcation area of the main PA. For non-atrial fibrillation patients, dual antiplatelet therapy for 1 month after PADN is recommended. Patients with atrial fibrillation should continue new oral anticoagulants and patients who underwent metal valve replacement should continued oral warfarin anticoagulation according to guidelines, which could determined by the physician.

Sponsors & Collaborators

  • Pulnovo Medical (Wuxi) Co., Ltd.

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-19
Primary Completion
2028-12-30
Completion
2028-12-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07039604 on ClinicalTrials.gov